Advice Pool - Reference and Education

Some authorities say that up to 60 percent of psychiatric patients, both in-patient and out-patient, report childhood histories of physical or sexual a

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

buse or both. This estimate excludes emotional abuse and neglect. My experience confirms that very many patients are suffering from PTSD (posttraumatic

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

stress disorder) as a direct result of childhood maltreatment. But they do not know what their real problem is.

Psychologists and psychiatrists know

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

what to expect in the way of symptoms with war veterans: PTSD. We know as fact that the experiences of war can produce in even the strongest individual

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

the constellation of symptoms that therapists should recognize as trauma. But for some reason, we have only begun to make this same connection with pe

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ple whose lives have been a “war.”

One woman, who spent nearly 20 years in therapy, first with an educational counselor, then three psychiatrists, plu

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

s a family therapist, found herself with suicidal feelings right up to the time she entered our group for domestic abuse. One psychiatrist, an analyst,

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

spent two years asking her, “What do you think?” Another psychiatrist gave her open prescriptions for highly addictive drugs, and the third psychiatri

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

st wanted to use electroconvulsive therapy, probably the worst possible treatment for trauma survivors. The family therapist ordered her to draw a fami

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ly geneology chart.

None of the above professionals seemed determined to find the cause of her suffering; they just had their favorite ways of treatin

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

symptoms. Her real problem had been nightly incest at the hands of her biological father, the rejection by her mother as a result, and constant debasi

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ng comments by both parents and both sisters all of her life. Not even her head-banging, a dead giveaway for sexual abuse, was noticed.

Another woman

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

was in treatment for thirty years for depression and a “borderline personality disorder,” ten of these years with the same psychiatrist. When the decad

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e had passed, he remarked, “I really don’t think I can help you.” Never was her sadistically violent tormentor, her husband, ever seen or even asked a

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

bout. She in no way had a borderline personality disorder, but she was indeed suffering from PTSD as a result of life-long abuse.

None of her therapis

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

s had been interested in causality. A disinterest in root cause is, in my opinion, the greatest weakness in the mental-health professions. We have clun

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

g so closely to the medical model that emotional disturbances of most any kind have historically been seen as free-standing, as though they had arisen

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

from an infection, from a vacuum, or from nowhere. How this mentality has survived is a mystery, when in any other science the principle of cause and e

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ffect rules.

Put another way, for every action there is a reaction. Molest, torture, humiliate, or neglect a child severely enough, and PTSD or simila

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

r symptoms will be the reaction. For this reason, the treatment of domestic abuse is the treatment of child abuse, and both are the treatment of trauma

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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